BreathRx with Zytex

Manufacturer
Discus Dental, LLC
Effective date
2022-12-16
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
legacy-cache
Hydrated at
2026-08-01 21:44:19

Label at a glance#

ProductBreathRx with Zytex
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure9 sections

Dosage and administration

Do not swallow rinse. Adults and children 12 years of age and older: vigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out. Children 6 years to under 12 years: supervise use. Children under 6 years of age: do not use

Storage and handling

Store at controlled room temperature 15°–30°C (59°–86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium chloride 0.075%

Purpose

OTC - PURPOSE SECTION

Antibacterial, antiplaque, antigingivitis

Use

INDICATIONS & USAGE SECTION

Helps prevent plaque that leads to gingivitis

Helps fight odor-causing bacteria

Warnings

WARNINGS SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Do not use if seal is broken.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

Do not swallow rinse.

Adults and children 12 years of age and older: vigorously swish 1/2 oz. (20 mL) of rinse, twice a day, for 30 seconds then spit out.
Children 6 years to under 12 years: supervise use.
Children under 6 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°–30°C (59°–86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Blue 1, Citric acid, Cocamidopropyl Betaine, Flavor (Mint, Thymol and Eucalyptus Oil), PEG-40 Hydrogenated Castor oil, Poloxamer 407, Propylene Glycol, Sodium Saccharin, Sorbitol, Water, Xylitol, Zinc gluconate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 oz. - Front Label2 oz. - Front Label

2 oz. - back label2 oz. - back label

2 oz. - carton2 oz. - carton

2 oz. - carton - drug facts2 oz. - carton - drug facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64854-01464854-014-10, 64854-014-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0f15d5db-b283-cd4b-e063-6294a90a63657be515f1-4aa5-6a9d-e053-2991aa0a37d12024-01-16WarningsExact identifier
spl set id: 7be515f1-4aa5-6a9d-e053-2991aa0a37d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.